Octagam 10% solution for infusions of 100 mg/ml 100 ml 1 pc.

Octagam ^® 10% is normal immunoglobulin solution (grade G) with a broad spectrum of antibodies against pathogens of various infections. The drug made from pooled plasma derived from donors not less than 3,500 and contains antibodies present in the plasma of healthy humans.

Immunoglobulin G molecules are not subject to change due to chemical or enzymatic action, activity antibody completely preserved. The distribution of immunoglobulin G subclasses closely to that in native human plasma.

The effective dose of the drug reduced the low level of immunoglobulin G to its normal value. The drug has immunomodulatory properties.

Active substance:
Immunoglobulin human normal

Manufacturer

Octapharma AG, Austria

Composition

1 ml of solution contains:

100 mg plasma protein including IgG is not less than 95%

Excipients:

maltose,

tributyl,

octoxynol,

water d / and.

Indications

Replacement Therapy: primary immunodeficiency syndromes (congenital agammaglobulinemia and hypogammaglobulinemia, ungraded variable and severe combined immunodeficiency, Wiskott-Aldrich syndrome), secondary hypogammaglobulinemia in patients with chronic lymphocytic leukemia and multiple myeloma, accompanied by repeated infections.

Immunomodulatory therapy: idiopathic thrombocytopenic purpura with high risk of bleeding or prior to surgery (to correct the platelet count), Kawasaki’s disease, bone marrow transplant.

Allogeneic bone marrow transplantation.

Contraindications

Increased sensitivity to the drug; intolerance or hypersensitivity to homologous immunoglobulins, especially in very rare cases of immunoglobulin A deficiency, when the patient contains antibodies to immunoglobulin A.

Carefully. Caution should be exercised when administering the drug to patients with obesity, as well as in patients with predisposing risk factors for thrombotic events such as advanced age, hypertension, diabetes, diseases of the circulatory system, the propensity to develop thrombosis, long stay in a fixed position, severe hypovolemia , diseases accompanied by increased blood viscosity. This is due to a relative increase in blood viscosity immunoglobulin entering the bloodstream, increasing the risk of myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis.

Because of the possible development of acute renal insufficiency Caution should be exercised when administered intravenously immunoglobulin patients with renal insufficiency, diabetes mellitus, obesity, hypovolemia, elderly patients (over 65 years), as well as patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, drug overturned immediately.

Patients groups at risk of acute renal failure and thromboembolic complications of the drug is administered at the minimum speed and in minimal doses.

Use in elderly patients

Caution should be exercised when administering the drug to patients with predisposing risk factors for thrombotic events such as, for example, old age.

Because of the possible development of acute renal insufficiency Caution should be exercised when administered intravenously immunoglobulin elderly patients (over 65 years), as well as patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, drug overturned immediately.

Use in renal function

Because of the possible development of acute renal failure should be careful when IVIG to patients with renal insufficiency and in patients receiving concomitant therapy with nephrotoxic drugs. In the case of acute renal failure, drug overturned immediately.

Patients groups at risk of acute renal failure and thromboembolic complications of the drug is administered at the minimum speed and in minimal doses.

Side effects

When on / in the immunoglobulin development of side effects depends on the dose and rate of administration.

The incidence of adverse events classified as follows: frequently (≥1% – < 10%), rare (≥0.1% – < 1%), very rarely (< 0.01%).

From the blood system and lymphatic system: very rarely – leukopenia, reversible hemolytic anemia, hemolysis.

Immune system: often – a hypersensitivity reaction; very rarely – anaphylactic and anaphylactoid (including anaphylactic shock) reaction, angioedema, swelling of the face.

From the nervous system: often – headache; very rare-stimulation, cerebral blood flow (including – stroke), aseptic meningitis, headache, dizziness, paresthesia.

With the cardiovascular system: very rarely – myocardial infarction, tachycardia, palpitation, cyanosis, thrombosis, circulatory failure, hypotension, hypertension, deep vein thrombosis.

The respiratory system: very rare – respiratory failure, pulmonary embolism, pulmonary edema, bronchospasm, dyspnea, and cough.

Gastro-intestinal tract: often – nausea; very rarely – vomiting, diarrhea, abdominal pain.

Skin: rarely – eczema; very rarely – urticaria, rash (including – erythematous), dermatitis, pruritus, alopecia.

On the part of the musculoskeletal system: rarely – pain in the back; very rarely – arthralgia, myalgia.

From the urinary system: very rarely – acute renal failure, elevated serum creatinine concentration in the blood.

From the laboratory parameters: very rarely – increased values ​​of “liver” enzymes, false positive increase in the concentration of glucose in the blood.

Other: often – fever, fatigue, injection site reactions; nechasto- chills, chest pain; very rarely – flushing, pyrexia, rash, and malaise. Rarely may develop a sudden drop in blood pressure, and in some cases – anaphylactic shock, including patients who are intravenous immunoglobulin previously tolerated.

How to accept, acceptance rate and dosage

The drug is injected in /. Before starting the administration, the solution temperature should be brought to room temperature. The solution should be clear or slightly opalescent. Do not use turbid and the precipitate containing solutions.

Each administration of the drug is recommended to register the name and number of the series in the history of the disease or the patient’s medical card in order to be able to trace the relationship of the patient with the introduction of a specific series of drug. Any amount remaining after infusion should be destroyed. The initial rate of introduction – from 0.01 to 0.02 ml / kg body weight per minute for 30 minutes. If the drug was well tolerated, the introduction rate can be gradually increased to a maximum of 0.12 ml / kg body weight per minute.

The dosage regimen of the drug and duration of therapy are selected individually, depending on the indication, pharmacokinetic and clinical response in a particular patient.

Replacement therapy in primary immunodeficiency

Mode of administration should achieve a concentration of immunoglobulin G, measured before each subsequent infusion, within at least – 4.0-6.0 g / l. Since the beginning of treatment, this requires 3 to 6 months. The recommended starting dose is 0.4-0.8 g / kg body weight, followed by administration 0.2 g / kg body weight every three weeks. The dose required to achieve a concentration of 6.0 g / l, is from 0.2 to 0.8 g / kg body weight per month. The interval between injections after reaching the equilibrium state is from 2 to 4 weeks. In order to correct dosing regimen should measure the concentration of immunoglobulin G before each subsequent infusion.

Replacement therapy in myeloma or chronic lymphatic leukemia with severe secondary hypogammaglobulinemia and recurrent infections; in children with congenital HIV infection and recurrent infections.

The recommended dose is 0.2-0.4 g / kg body weight every 3-4 weeks.

Idiopathic thrombocytopenic purpura (ITP)

In the treatment of acute episodes – 0.8-1.0 g / kg body weight on the first day, with repeated administration, if necessary, on the third day, or 0.4 g / kg body weight per day for 2-5 days. Treatment may be repeated in the case of repeated episodes.

Guillain-Barré syndrome

0.4 g / kg body weight per day for 3-7 days. Experience of application in children is limited.

Kawasaki disease

1.6-2.0 g / kg of body weight are administered in equal doses over 2-5 days or once in a dose 2.0 g / kg body weight. Patients should simultaneously take acetylsalicylic acid.

Marrow allografting

Immunoglobulin is used as a preparatory treatment of the component, and after transplantation. In the treatment of infectious complications and to prevent the development of the syndrome of “graft versus host” dose picked individually. The recommended starting dose is 0.5 g / kg body weight per week starting 7 days before transplantation. Treatment was continued for 3 months after transplantation. In the case of a constant immunoglobulin deficiency recommended administered 0.5 g / kg body weight per month as long as the immunoglobulin level normalizes.

Storage conditions

In the dark place at a temperature of 2-8 ° C (not frozen)

Active substance

Immunoglobulin human normal

Interaction

The introduction of the drug may reduce the efficacy of live attenuated virus vaccines (measles, smallpox, rubella, mumps, chicken pox) for a period of 6 weeks to 3 months.

Before the vaccination with live attenuated vaccines should be at least 3 months after treatment. In the case of vaccines against measles, this effect may persist for up to 1 year.

In this regard, before application of measles vaccine must be checked measles antibody titer.

Special conditions

Due to the fact that the development of certain side effects may be related to the rate of administration should strictly comply with the instructions. During the administration should carefully monitor the patient.

For all patients receiving intravenous immunoglobulin, necessary to carry out adequate hydration before infusion, monitor urine output, control of the concentration of creatinine in plasma, to eliminate the use of “loop” diuretics.

In case of side effects should be reduced or the drug administration rate to completely stop it. Treatment depends on the nature and severity of side effects. In the case of shock should begin protivoshokovoe treatment in accordance with the applicable standard of care.

Most side reactions can often occur at a high injection rate at hypo- and agammaglobulinemia (compared to immunoglobulin A or without deficiency), when administered immunoglobulin for the first time, in rare cases – when translated into immunoglobulin from another manufacturer, or after a long period of time after the last infusion. Such patients should be observed during the first infusion period, and for 1 hour after administration. Other patients should be observed during the first 20 min of infusion.

Standard measures to prevent infections caused by using medicaments produced from human blood or plasma include selection of donors, and by individual portions of plasma pools for specific markers of infection and inclusion in the process of production of effective measures for the inactivation / elimination of viruses. Nevertheless, we can not completely exclude the possibility of transfer of infectious diseases.

It also relates to the unexpected or newly identified viruses or other pathogenic microorganisms. These measures are considered effective for enveloped viruses – HIV, hepatitis B and hepatitis C, and to a lesser extent – with regard to the hepatitis A virus and parvovirus B19. Growing clinical experience with human immunoglobulin preparations convincing evidence that hepatitis A virus and parvovirus B19 is not transferred to the treatment with these drugs.

A greater role in ensuring the safety of the antiviral is the presence in the formulation of appropriate antibodies. In treatment of various transient increase passively transferred antibodies in the blood of the patient could lead to false positive results of serologic tests. Passive transfer of antibodies to red cell antigens (e.g., A, B, D), may affect some serological tests erythrocytic allo-antibodies (e.g., Coombs test).

Due to the presence of maltose in the composition of the drug (90 mg / ml) is possible false positive increase in glucose concentration in the blood of the patient, determined by means of some test kits (e.g., enzyme-based glyukozodegidrogenazy- pyrroloquinoline quinone or via glucose-di oksireduktaznoy reaction) . Elevated concentrations of blood glucose are determined during the administration and within 15 hours after its closure.

In this regard, perhaps unnecessary use of insulin and, as a consequence – the development of hypoglycemia. Such false positive results can also mask the existing hypoglycemia, because of which the patient will not be assigned appropriate therapy. Thus, when using the drug Octagam ^® 10%, as the application of other parenteral solutions containing maltose, use glyukozospetsificheskie methods for determining blood glucose levels.

Therefore, when studying the instructions for test kit (including test strips) for determining the concentration of glucose in the blood is necessary to pay special attention to the possibility of its use in patients receiving medications containing maltose.

During the shelf life of the drug can be stored at temperatures up to 25 ° C for 3 months without re space in the refrigerator. Unused during this time should be to destroy the drug.

The drug does not appear to have any effect on the ability to drive or perform work that requires high concentration and psychomotor reactions.

Overdose

symptoms:

• water retention in the body;
• increase blood viscosity (especially in patients with impaired renal function or in old age).

Treatment: symptomatic.